Subcutaneous implantable medical devices with anti-microbial agents for chronic release

Abstract

An anti-microbial component of the IMD that is exposed to body fluids in the pocket is compounded of an anti-microbial metal ion zeolite that elutes metal ions in concentrations exhibiting anti-microbial activity over a substantial period of time of implantation is disclosed. The anti-microbial component is physically attached to the IMD to be retained in close proximity and in a stable location in the subcutaneous pocket. In another embodiment, the anti-microbial component conforms to the shape of the IMD and is attachable to and detachable from the IMD. In another embodiment, the polymeric component includes a connector header of an IPG or a monitor, or a connector sleeve or the sealing rings of a proximal connector assembly of an electrical medical lead coupled with an IPG or monitor that are located in the subcutaneous pocket or in the backing of a subcutaneously implanted cardioversion/defibrillation (C/D) electrode.

1 . A method of providing anti-microbial protection in a subcutaneous pocket in which an implantable medical device (IMD) having a predetermined IMD shape is implanted comprising: 
 providing an anti-microbial component that conforms to the IMD shape and is selectively attachable to and detachable from the IMD;    attaching the anti-microbial component to the IMD; and    implanting the IMD and the anti-microbial component within the subcutaneous pocket.    
     
     
         2 . The method of  claim 1 , wherein the providing step further comprises: compounding a biocompatible polymer with a metal ion zeolite in sufficient concentration to provide anti-microbial activity by elution of metal ions into body fluids; and 
 molding the compounded biocompatible polymer with the metal ion zeolite into the anti-microbial component into a thin-walled, elastic boot adapted to fit over at least a portion of the IMD that is wettable by body fluids to enable elution of the metal ions into body fluid.    
     
     
         3 . The method of  claim 2 , wherein the metal ions are selected from the group consisting of silver, gold, platinum, palladium, iridium, antimony, arsenic, selenium, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium ions.  
     
     
         4 . The method of  claim 3 , wherein the IMD comprises one of the group consisting of an electrode, an implantable pulse generator, and a drug pump.  
     
     
         5 . The method of  claim 2 , wherein the molding step further comprises molding the elastic boot with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening facilitating insertion of the IMD into the boot cavity in the attaching step and removal of IMD from the boot cavity.  
     
     
         6 . The method of  claim 5 , wherein the IMD supports an electrode surface, and the attaching step comprises aligning the at least one opening in relation to the electrode surface to expose the electrode surface.  
     
     
         7 . The method of  claim 1 , wherein the providing step further comprises molding the anti-microbial component as a thin-walled, elastic boot adapted to fit over at least a portion of the IMD.  
     
     
         8 . The method of  claim 7 , wherein the molding step further comprises molding the elastic boot with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening facilitating insertion of the IMD into the boot cavity in the attaching step and removal of IMD from the boot cavity.  
     
     
         9 . The method of  claim 8 , wherein the IMD supports an electrode surface, and the attaching step comprises aligning the at least one opening in relation to the electrode surface to expose the electrode surface.  
     
     
         10 . The method of  claim 1 , wherein the providing step further comprises molding the anti-microbial component as a thin-walled, elastic pad adapted to be attached to at least a portion of the IMD.  
     
     
         11 . The method of  claim 1 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.  
     
     
         12 . A method of providing anti-microbial protection in a subcutaneous pocket in which an implantable medical device (IMD) having a biocompatible polymeric component is implanted comprising: 
 forming at least a portion of the polymeric component of the IMD with an anti-microbial IMD component; and    implanting the IMD with the anti-microbial IMD component within the subcutaneous pocket.    
     
     
         13 . The method of  claim 12 , wherein the forming step further comprises: compounding a biocompatible polymer with a metal ion zeolite in sufficient concentration to provide anti-microbial activity by elution of metal ions into body fluids; and 
 molding the compounded biocompatible polymer with the metal ion zeolite into the anti-microbial IMD component.    
     
     
         14 . The method of  claim 13 , wherein the metal ions are selected from the group consisting of silver, gold, platinum, palladium, iridium, antimony, arsenic, selenium, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium ions.  
     
     
         15 . The method of  claim 13 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a connector assembly that is received in a connector bore of the connector assembly, and the molding step comprises molding at least a portion of the connector header of the compounded biocompatible polymer and metal ion zeolite.  
     
     
         16 . The method of  claim 15 , wherein the IPG comprises one of the group consisting of a group consisting of sacral nerve stimulator IPG, a spinal cord stimulator IPG, a cardiac pacing IPG, a deep brain stimulator IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         17 . The method of  claim 13 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a connector assembly that is received in a connector bore of the connector assembly, and the molding step comprises molding at least a portion of the connector assembly of the compounded biocompatible polymer and metal ion zeolite.  
     
     
         18 . The method of  claim 17 , wherein the IPG comprises one of the group consisting of a sacral nerve stimulator IPG, a spinal cord stimulator IPG, a deep brain stimulator IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         19 . The method of  claim 13 , wherein the IMD comprises a subcutaneously implantable electrode comprising a conductive electrode surface supported on a polymeric backing, and the molding step comprises molding at least a portion of the polymeric backing of the compounded biocompatible polymer and metal ion zeolite.  
     
     
         20 . The method of  claim 13 , wherein the IMD comprises an implantable monitor having a polymeric header, and the molding step comprises molding at least a portion of the header of the compounded biocompatible polymer and metal ion zeolite.  
     
     
         21 . The method of  claim 13 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.  
     
     
         22 . Apparatus for providing anti-microbial protection in a subcutaneous pocket in which an implantable medical device (IMD) having a predetermined IMD shape is implanted comprising: 
 an anti-microbial component shaped to conform to the shape of the IMD; and means for attaching the anti-microbial component to the IMD.    
     
     
         23 . The apparatus of  claim 22 , wherein the anti-microbial component is compounded of a biocompatible polymer with a metal ion zeolite in sufficient concentration to provide anti-microbial activity by elution of metal ions into body fluids.  
     
     
         24 . The apparatus of  claim 23 , wherein the metal ions are selected from the group consisting of silver, gold, platinum, palladium, iridium, antimony, arsenic, selenium, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium ions.  
     
     
         25 . The apparatus of  claim 23 , wherein the IMD comprises one of the group consisting of an electrode, an implantable pulse generator, and a drug pump.  
     
     
         26 . The apparatus of  claim 23 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.  
     
     
         27 . The apparatus of  claim 22 , wherein the anti-microbial component is compounded of a biocompatible polymer with a metal ion zeolite in sufficient concentration to provide anti-microbial activity by elution of metal ions into body fluids, and the anti-microbial component is molded into a thin-walled, elastic boot adapted to fit over at least a portion of the IMD that is wettable by body fluids to enable elution of the metal ions into body fluid.  
     
     
         28 . The apparatus of  claim 27 , wherein the metal ions are selected from the group consisting of silver, gold, platinum, palladium, iridium, antimony, arsenic, selenium, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium ions.  
     
     
         29 . The apparatus of  claim 27 , wherein the IMD comprises one of the group consisting of an electrode, an implantable pulse generator, and a drug pump.  
     
     
         30 . The apparatus of  claim 27 , wherein the elastic boot is molded with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening facilitating insertion of the IMD into or removal of the IMD from the boot cavity.  
     
     
         31 . The apparatus of  claim 27 , wherein the IMD supports an electrode surface, and the elastic boot is molded with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening adapted to be aligned with the electrode surface to expose the electrode surface.  
     
     
         32 . The apparatus of  claim 22 , wherein the anti-microbial component is compounded of a biocompatible polymer with an anti-microbial agent in sufficient concentration to provide anti-microbial activity by elution of anti-microbial agent into body fluids, and the anti-microbial component is molded into a thin-walled, elastic boot adapted to fit over at least a portion of the IMD that is wettable by body fluids to enable elution of the metal ions into body fluid.  
     
     
         33 . The apparatus of  claim 32 , wherein the elastic boot is molded with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening facilitating insertion of the IMD into or removal of the IMD from the boot cavity.  
     
     
         34 . The apparatus of  claim 32 , wherein the IMD supports an electrode surface, and the elastic boot is molded with an internal boot cavity shaped to receive at least a portion of the IMD and at least one opening adapted to be aligned with the electrode surface to expose the electrode surface.  
     
     
         35 . The apparatus of  claim 22 , wherein the anti-microbial component is compounded of a biocompatible polymer with an anti-microbial agent in sufficient concentration to provide anti-microbial activity by elution of anti-microbial agent into body fluids, and the anti-microbial component is molded into a thin-walled, elastic pad adapted to fit against and attached to at least a side of the IMD that is wettable by body fluids to enable elution of the metal ions into body fluid.  
     
     
         36 . The apparatus of  claim 22 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.  
     
     
         37 . A apparatus for providing anti-microbial protection in a subcutaneous pocket in which an implantable medical device (IMD) is implanted comprising: 
 an IMD housing formed at least in part of a biocompatible polymeric component; and    an anti-microbial agent incorporated into the biocompatible polymeric component to provide an anti-microbial IMD component providing anti-microbial activity by elution of anti-microbial agent into body fluids.    
     
     
         38 . The apparatus of  claim 37 , wherein the anti-microbial IMD component is compounded of a biocompatible polymer with a metal ion zeolite in sufficient concentration to provide anti-microbial activity by elution of metal ions into body fluids and molded into a component shape.  
     
     
         39 . The apparatus of  claim 38 , wherein the metal ions are selected from the group consisting of silver, gold, platinum, palladium, iridium, antimony, arsenic, selenium, copper, zinc, mercury, tin, lead, bismuth, cadmium, chromium and thallium ions.  
     
     
         40 . The apparatus of  claim 38 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a connector assembly that is received in a connector bore of the connector assembly, and the anti-microbial IMD component comprises at least a portion of the connector header.  
     
     
         41 . The apparatus of  claim 40 , wherein the IPG comprises one of the group consisting of a sacral nerve stimulator IPG, a spinal cord stimulator IPG, a deep brain stimulator IPG, a cardiac pacing IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         42 . The apparatus of  claim 38 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a lead connector assembly that is received in a connector bore of the connector assembly, and the anti-microbial IMD component comprises at least a portion of the lead connector assembly.  
     
     
         43 . The apparatus of  claim 42 , wherein the IPG comprises one of the group consisting of a sacral nerve stimulator IPG, a spinal cord stimulator IPG, a deep brain stimulator IPG, a cardiac pacing IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         44 . The apparatus of  claim 38 , wherein the IMD comprises a subcutaneously implantable electrode comprising a conductive electrode surface supported on a polymeric backing, and the anti-microbial IMD component comprises at least a portion of the polymeric backing.  
     
     
         45 . The apparatus of  claim 38 , wherein the IMD comprises an implantable monitor having a polymeric header, and the and the anti-microbial IMD component comprises at least a portion of the header.  
     
     
         46 . The apparatus of  claim 38 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.  
     
     
         47 . The apparatus of  claim 37 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a connector assembly that is received in a connector bore of the connector assembly, and the anti-microbial IMD component comprises at least a portion of the connector header.  
     
     
         48 . The apparatus of  claim 47 , wherein the IPG comprises one of the group consisting of a sacral nerve stimulator IPG, a spinal cord stimulator IPG, a deep brain stimulator IPG, a cardiac pacing IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         49 . The apparatus of  claim 48 , wherein the IMD comprises the combination of one of the group consisting of an implantable pulse generator (IPG) and a monitor, each having a connector header, combined with an electrical medical lead having a lead connector assembly that is received in a connector bore of the connector assembly, and the anti-microbial IMD component comprises at least a portion of the lead connector assembly.  
     
     
         50 . The apparatus of  claim 49 , wherein the IPG comprises one of the group consisting of a sacral nerve stimulator IPG, a spinal cord stimulator IPG, a deep brain stimulator IPG, a cardiac pacing IPG, and an implantable cardioverter/defibrillator IPG formed of a single IPG module or plural IPG modules.  
     
     
         51 . The apparatus of  claim 48 , wherein the IMD comprises a subcutaneously implantable electrode comprising a conductive electrode surface supported on a polymeric backing, and the anti-microbial IMD component comprises at least a portion of the polymeric backing.  
     
     
         52 . The apparatus of  claim 48 , wherein the IMD comprises an implantable monitor having a polymeric header, and the and the anti-microbial IMD component comprises at least a portion of the header.  
     
     
         53 . The apparatus of  claim 48 , wherein the IMD comprises one of the group consisting of a sacral nerve stimulator implantable pulse generator (IPG), a spinal cord stimulator IPG, a deep brain stimulator IPG, a spinal cord drug pump, a deep brain drug pump, a cardiac pacing IPG, an implantable cardioverter defibrillator IPG, a cardiac hemodynamic monitor, a cardiac monitor, and a cardioversion/defibrillation electrode.